Q2 Blood Administration Sets
Summary
Quest Medical, Inc. received 510(k) clearance for Q2 Blood Administration Sets, a FPA device. Cleared on 2022-06-05.
Details
Source
510(k) Clearance
External ID
K213846
Action Date
2022-06-05
Status
Traditional
Category
device
Product Code
FPA
Product Description
Q2 Blood Administration Sets. Product code: FPA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Quest Medical, Inc. has received 3 total clearances in our database.
Quest Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Quest Medical, Inc. have FDA actions?
Quest Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213846" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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